cetrorelix acetate

NDC product · U.S. Food and Drug Administration (openFDA) · United States

Product NDC 68083-600
Package NDC 68083-600-01
Application number ANDA218150
SPL ID ab90e510-eecd-4d5f-b2df-059d3cbfc8f0
SPL set ID 89f8f8ee-68ac-4ed0-a7e3-ffd6e0c1290a
RxCUI 283402

What the source publishes

Labeler: Gland Pharma Limited
Active ingredients: cetrorelix acetate
Form: KIT
Administrative status: present-in-source-snapshot
Marketing status: ANDA
Product type: HUMAN PRESCRIPTION DRUG
Prescription: Prescription or restricted

Names this record is found by

cetrorelix acetate

Complete source data

us:fda:ndc:68083-600_ab90e510-eecd-4d5f-b2df-059d3cbfc8f0

{
  "name": "cetrorelix acetate",
  "splId": "ab90e510-eecd-4d5f-b2df-059d3cbfc8f0",
  "labels": [
    {
      "setId": "89f8f8ee-68ac-4ed0-a7e3-ffd6e0c1290a",
      "labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=89f8f8ee-68ac-4ed0-a7e3-ffd6e0c1290a",
      "labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=89f8f8ee-68ac-4ed0-a7e3-ffd6e0c1290a"
    }
  ],
  "routes": [],
  "labeler": "Gland Pharma Limited",
  "finished": true,
  "packaging": [
    {
      "sample": false,
      "description": "1 TRAY in 1 CARTON (68083-600-01)  / 1 KIT in 1 TRAY *  1 mL in 1 VIAL, SINGLE-DOSE (68083-598-01)  *  1 mL in 1 SYRINGE (68083-599-01)",
      "package_ndc": "68083-600-01",
      "identifierStatus": "well-formed",
      "marketing_start_date": "20240425"
    }
  ],
  "productId": "68083-600_ab90e510-eecd-4d5f-b2df-059d3cbfc8f0",
  "useDomain": "unknown",
  "dosageForm": "KIT",
  "productNdc": "68083-600",
  "deaSchedule": null,
  "genericName": "cetrorelix acetate",
  "productType": "HUMAN PRESCRIPTION DRUG",
  "listingStatus": "present-in-source-snapshot",
  "targetSpecies": [],
  "approvalStatus": "not-established-by-ndc-listing",
  "labelAssociation": "openFDA-harmonized-set-ids; not a product-level approval match",
  "marketingEndDate": null,
  "activeIngredients": [],
  "applicationNumber": "ANDA218150",
  "marketingCategory": "ANDA",
  "stateRestrictions": {
    "status": "not-collected",
    "observations": []
  },
  "useDomainEvidence": {
    "basis": "unreviewed",
    "field": null,
    "value": null,
    "version": 1,
    "sourceId": "us.fda.ndc"
  },
  "marketingStartDate": "20240425",
  "targetSpeciesStatus": "not-reported",
  "prescriptionCategory": "prescription-or-restricted",
  "harmonizedIdentifiers": {
    "rxcui": [
      "283402"
    ],
    "spl_set_id": [
      "89f8f8ee-68ac-4ed0-a7e3-ffd6e0c1290a"
    ],
    "manufacturer_name": [
      "Gland Pharma Limited"
    ],
    "is_original_packager": [
      true
    ]
  },
  "listingExpirationDate": "20271231"
}

NDC Directory

U.S. Food and Drug Administration / openFDA

Retrieved: November 11, 2026
Licence: CC0 1.0
Source id: us.fda.ndc

Official source

What this source does not establish

Complete published endpoint, not a claim that FDA lists every medicine used in the US.
NDC listing, marketing category and application-number assertions are not proof of approval.
Tentative approval, discontinued products and historical submissions remain distinct.
Official document links only; linked documents have not been relicensed or mirrored.
No state restrictions, individual eligibility, or prescribing recommendations inferred.
UNII and RxNorm identifiers are source-asserted openFDA harmonization at record scope; arrays do not pair identifiers to individual products or ingredients, and are not GSID/PhPID or substitution evidence.

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